Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with t

FDA device recall Z-0424-2015 · posted 2014-11-24 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.

Action taken

On 10/14/2014, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected distributors and hospital Risk Managers. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call the customer call center at 1-877-946-2761.

Root cause

Labeling design

Status

Terminated

Product code

HWA

Quantity affected

4961 units

Distribution

Worldwide Distribution - US Nationwide in the state of AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, ND, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, WI, NC, TN, OK, AZ, UT, AK, P

Date initiated

2014-10-14

Date posted

2014-11-24

Date terminated

2015-06-09

Location

Warsaw, IN